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Public advocacy group asks federal court to force FDA to release records on xenotransplantation risks.

The Campaign for Responsible Transplantation (CRT), a New York-based "advocacy group" has asked the Federal District Court for the District of Columbia to compel the US Food and Drug Administration (FDA) to release records that they allege contain information on the potential risks of xenotransplantation.

The CRT's lawsuit, which was filed November 27, alleges that the FDA "repeatedly ignored [CRT's] requests" for information on animal-to-human transplant clinical trials.

"We want to court to rule that the FDA violated the Freedom of Information Act (FOIA) by withholding [xenotransplantation clinical data], CRT spokeswoman Alix Fano said, according to Reuters Health.

Fano claimed that based on a survey of medical journals by CRT more than 12 patients have died and numerous others have suffered serious side effects in the past 10 years after receiving tissue or organs from pigs and baboons.

An FDA spokesperson shrugged off the group's allegations, saying that the agency routinely responds to various groups regarding "why we do what we do and that the FDA's policy on xenotransplantation has been "well dealt with" through current public guidelines.
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Publication:Transplant News
Article Type:Brief Article
Date:Dec 29, 2000
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